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Regulation (EU) 2016/793 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2016/793 of the European Parliament and of the Council of 11 May 2016 to avoid trade diversion into the European Union of certain key medicines (codification)

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Article 1

1.This Regulation lays down:

(a)the criteria for establishing what is a tiered-priced product;

(b)the conditions under which the customs authorities shall take action;

(c)the measures which shall be taken by the competent authorities in the Member States.

2.For the purposes of this Regulation:

(a)‘tiered-priced product’ means any pharmaceutical product which is used in the prevention, diagnosis or treatment of a disease, referred to in Annex IV, and which is priced in accordance with one of the optional price calculations set out in Article 3, verified by the Commission or an independent auditor as provided for in Article 4 and entered in the list of tiered-priced products set out in Annex I;

(b)‘countries of destination’ means the countries listed in Annex II;

(c)‘competent authority’ means an authority designated by a Member State to determine whether goods suspended by the customs authorities in the respective Member State are tiered-priced products and to give instructions depending on the outcome of the review.

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